This proposal is for the University of Alabama at Birmingham School of Optometry (UABSO) to serve as a clinical center for the Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART), a multicenter randomized, placebo controlled, clinical trial designed to evaluate the effects of treatment for symptomatic convergence insufficiency (Cl) on measures of reading performance and attention in children. In this trial, 324 children aged 9 to <14 years with symptomatic 01 will be randomly assigned to 16 weeks of: 1) office-based vergence/ accommodative therapy with home-reinforcement or 2) office-based placebo therapy. After 16 weeks of treatment, the primary outcome measures of reading comprehension (Wechsler Individual Achievement test [WIAT-III]) reading comprehension subtest score and attention (Strengths and Weaknesses of ADHD Symptoms &Normal Behavior Scale [SWAN]) will be assessed by examiners masked to treatment group. The Gates MacGinitie-4 test, which uses a format similar to curriculum-based evaluation done in classrooms, will provide a secondary measure of reading comprehension. Reading fluency, another test of attention, the 01 Symptom Survey, and clinical measures of 01 (i.e., the near point of convergence, and positive fusional vergence at near) are other secondary outcome measures;also included are assessments of key reading and cognitive components that impact reading comprehension including pseudo word decoding, word reading, and listening comprehension. Long-term effects on reading achievement and attention are assessed 1 -year post treatment. This application documents our site's ability to recruit at least 36 subjects and to retain them for 1 year after completion of treatment. Documentation is provided that our site has the appropriate personnel, equipment, and facilities to conduct the study in accordance with the OITT-ART Manual of Procedures (MOP). Complete details of the study rationale, design, and methods are contained in the Manual of Procedures (submitted with the Study Chair and Data Coordinating Center [DOO] applications). In addition to our center, there are 8 other optometric or ophthalmologic centers, the Study Chair at the Pennsylvania College of Optometry at Salus University, and the DOO at The Ohio State University Optometry Coordinating Center. Symptomatic 01 is a common vision disorder in children that is commonly associated with symptoms while reading (e.g. loss of place, loss of concentration, frequent re-reading, reading slowly, and trouble remembering what was read). However, the effect of 01 treatment on reading and attention is unknown. The results of the proposed study will lead to a better understanding of these relationships and have important implications for educators, psychologists, and physicians who care for children with reading and attention problems. The findings will guide hypothesis development for future scientific investigations in children with vision disorders.

Agency
National Institute of Health (NIH)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10EY022594-01A1
Application #
8609684
Study Section
Special Emphasis Panel (ZEY1)
Program Officer
Redford, Maryann
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Other Health Professions
Type
Schools of Optometry/Opht Tech
DUNS #
City
Birmingham
State
AL
Country
United States
Zip Code
35294